Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices has published detailed guidelines dedicated to sponsorship with regard to placing medical devices on the Australian market. Regulatory Background According...
EU MDR/IVDR The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document describing the rules on healthcare institution exemption for medical devices. It is important to mention...
Australia and Oceania The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to the key performance aspects in the context of the applicable standards for...
Kazakhstan Kazakhstan has recently adopted new rules on clinical trials for medicines and medical devices, including clinical and laboratory examination of in vitro diagnostic medical devices. The new Order of the Minister of Healthcare of the Republic of Kazakhstan dated...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and healthcare products, has published detailed guidance dedicated to audits in the context of the Medical Device Single Audit Program (MDSAP). ...
